Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is work­ing on putting to­geth­er a late-stage study for its mon­o­clon­al an­ti­body Gazy­va in pa­tients with se­vere kid­ney dis­ease as­so­ci­at­ed with lu­pus af­ter a com­bi­na­tion ap­proach helped pa­tients in a mid-stage study.

The 125-pa­tient NO­BIL­I­TY tri­al eval­u­at­ed Gazy­va, com­bined with stan­dard-of-care treat­ment my­cophe­no­late mofetil or my­cophe­no­lic acid and cor­ti­cos­teroids, ver­sus stan­dard treat­ment alone. The com­bo met the main goal of in­duc­ing a sta­tis­ti­cal­ly su­pe­ri­or com­plete re­nal re­sponse (CRR) of 40% at week 76, ver­sus 18% in pa­tients giv­en stan­dard treat­ment, Roche said.

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